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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDAKOCYTOMATION HER2 FISH PHARMDX KIT
Generic NameSYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
ApplicantAgilent Technologies Singapore (International) Pte , Ltd.
# 1 Yishun Ave. 7
Singapore 768923
PMA NumberP040005
Date Received01/29/2004
Decision Date05/03/2005
Product Code MVD 
Docket Number 05M-0387
Notice Date 09/23/2005
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE DAKOCYTOMATION HER2 FISH PHARMDX KIT. THE DEVICE IS INDICATED FOR: THE DAKOCYTOMATION HER2 FISH PHARMDX KIT IS A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TO QUANTITATIVELY DETERMINE THE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED BREAST CANCER TISSUE SPECIMENS. HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED. RESULTS FORM THE HER2 FISH PHARMDX KIT ARE INTENDED FOR USE AS AN ADJUNCT TO THE CLINICOPATHOLOGIC INFORMATION CURRENTLY USED FOR ESTIMATING PROGNOSIS IN STAGE II, NODE POSITIVE BREAST CANCER PATIENTS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S004 S005 S008 S003 S002 S012 S014 S006 S010 S009 S011 
S007 S001 S013 
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